University of Rochester Center for AIDS Research (DCFAR) (P30)

Dates: 5/1/2013 - 4/30/2019


Role: James M McMahon, PhD : Co-Director, Clinical and Translational Sciences Core
Principal Investigator: Stephen Dewhurst

I am proposing to conduct a 5-year open-label prospective cohort study to examine uptake, adherence, safety, toxicity, drug level concentrations, clinical monitoring and HIV risk behaviors associated with scale-up of oral PrEP (tenofovir/emtricitabine; Truvada, Gilead Sciences, Inc.) across 20 HIV treatment settings in New York City. In order to establish the feasibility and significance of the proposed NIH PrEP study, I need to support the application with data on current provider policies, programs and implementation of oral PrEP (Truvada). Specifically, I need to demonstrate that (a) providers are beginning to scale up prescription of Truvada (establishing the feasibility of sample recruitment and the significance of exploring this implementation), (b) provider PrEP policies and programs are being formulated based on standard clinical protocols (establishing the type and quality of clinical measures to be collected at the provider level), and (c) providers express a willingness to participate in the proposed NIH funded project (establishing the clinical partnerships needed to conduct the proposed research). Therefore, I am requesting $2,500 in DCFAR Micro Grant funds to conduct a provider survey of NYC HIV treatment providers to generate this preliminary data in support of the above-mentioned NIH R01 grant application. The proposed survey study (NYC Provider PrEP Survey), for which I am requesting funds, will encompass both  quantitative and qualitative methods (i.e. a mix of survey response items and open-ended questions) administered to approximately 25-30 provider stakeholders (clinic directors and frontline providers) in a personal interview format (either in person or over the phone) lasting about 20-30 minutes. Interviews will be audio recorded, and subsequently reviewed for quantitative data extraction and qualitative narrative summaries and codification. As mentioned, survey findings will be used to support (and guide) the development of the proposed HIV PrEP R01. A manuscript will also be prepared for publication to disseminate the results.